MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA, INC. DORNIER MEDTECH; POWERED LASER SURGICAL INSTRUMENT

Model Number	270 MICRON SU THULIO SLIM PERFORMANCE 3M FIBER
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Laser fiber in use during laser lithotripsy of kidney stone.When fiber was removed from the bladder it was noted that the tip was frayed, and a portion of the tip was missing.

• Brand Name: DORNIER MEDTECH
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd.; kennesaw GA 30144
• MDR Report Key: 17919195
• Report Number: 17919195
• Device Sequence Number: 2956673
• Product Code: GEX
• UDI-Device Identifier: 00810116023271
• UDI-Public: (01)00810116023271(17)280317(10)F1123S
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2023
• Report Date (Section F): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 270 MICRON SU THULIO SLIM PERFORMANCE 3M FIBER
• Device Catalogue Number: K2016361
• Device Lot Number: F1123S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 57 KG
• Date Report Sent to FDA: 09/27/2023